Medical devices include Surgical Equipment, Diagnostic equipment like Cardiac imaging, CT scans, X-ray, Molecular Imaging, MRI and Ultrasound-imaging including hand - held devices; Life Support equipment like ventilator, etc. as well as Implants and Disposables.

§  Objectives:

o   The easy access to standard testing and infrastructure facilities through the creation of world-class common infrastructure facilities via medical device parks.

o   To reduce the cost of production of medical devices and the better availability and affordability of medical devices in the domestic market.

§  Financial Assistance:

o   The total financial outlay of the scheme is Rs 400 crore and the tenure of the scheme is from FY 2020-2021 to FY 2024-2025.

o   Financial assistance to a selected Medical Device Park would be 70% of the project cost of common infrastructure facilities.

·       In the case of the North-Eastern States and the Hilly States, financial assistance would be 90% of the project cost.

o   Maximum assistance under the scheme for one Medical Device Park would be limited to Rs. 100 crores.

o   The Centre has granted in-principal approval for the parks in Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh.

§  Medical Devices Sector in India:

o   The Medical Devices industry in India is valued at USD 5.2 billion, contributing about 4-5% to the USD 96.7 billion Indian healthcare Industry.

o   Medical devices sector in India is very small in size as compared to the rest of the manufacturing industry, though India is one of the top twenty markets for medical devices in the world and is the 4^th largest market in Asia after Japan, China, and South Korea.

o   India currently imports 80-90% of medical devices of the USD15 billion market.

·       The US, Germany, China, Japan, and Singapore constitute the five largest exporters of high technology medical equipment to India.

§  Related Initiatives:

o   In June 2021, the Quality Council of India (QCI) and the Association of Indian Manufacturers of Medical Devices (AiMeD) launched the Indian Certification of Medical Devices (ICMED) 13485 Plus scheme to undertake verification of the quality, safety and efficacy of medical devices.

o   To boost domestic manufacturing of medical devices and attract huge investments in India, the department of pharmaceuticals launched a PLI scheme for domestic manufacturing of medical devices, with a total outlay of funds worth Rs.3,420 crore for the period FY21-FY28.

o   The Ministry of Health and Family Welfare has notified that medical equipment would qualify as ‘drugs’ under Section 3 of the Drugs and Cosmetics Act (D & CA), 1940 from 1^st April, 2020.

o   The Medical Devices Parks have been set up in Andhra Pradesh, Telangana, Tamil Nadu and Kerala.

·       In 2020, Kerala established MedSpark, one of the first medical device parks in the country, in Thiruvananthapuram.

o   The Government of India recognised medical devices as a sunrise sector under the ‘Make in India’ campaign in 2014.